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USFDA Guidance: Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter (OTC) Monograph Drugs
Before submitting an Over-the-Counter (OTC) Monograph Order Request (OMOR) or advancing the development of an OTC monograph drug, early engagement with the U.S. Food and Drug Administration (FDA) can help sponsors clarify regulatory expectations, discuss scientific evidence, and address potential development challenges. Structured interactions with the Agency allow sponsors to obtain timely feedback, improve development planning, and support efficient regulatory decision-maki
Sharan Murugan
3 hours ago4 min read